Method for injecting X-ray contrast media for venography of the female pelvis

ABSTRACT

A method for injecting x-ray contrast media into the wall of the uterus a predetermined depth to make a record of the venous plexus system of the uterus. A straight rod probing member having a probing surface for probing against the uterine wall is inserted into the uterus and a piercing member arranged to be combined with a syringe is slidably disposed in the probing member and extended a predetermined amount from the probing surface when the probing surface contacts the uterine wall. X-ray opaque material is then injected into the spongy layer of the uterus and an X-ray record made of the passage of said opaque material through the venous plexus system.

United States Patent [191 Hartnett [451 May 20, 1975 METHOD FOR INJECTING X-RAY CONTRAST MEDIA FOR VENOGRAPHY OF THE FEMALE PELVIS 21 Appl. No.2 399,424

Related US. Application Data [63] Continuation of Ser. No. 269,038, July 5, 1972,

abandoned.

[52] US. Cl. 128/2 A; 128/215 [51] Int. Cl A61b 6/00 [58] Field of Search 128/2 A, 2 R, 2 B, 215, 128/216, 221, 347, 245, 260

[56] References Cited UNITED STATES PATENTS 1,213,001 1/1917 Philips 128/347 2,283,915 5/1942 Cole 128/218 C 2,700,385 1/1955 Ortiz 1 128/215 2,712,314 7/1955 Kohl 1 128/215 2,740,404 4/1956 Kohl 128/215 2,850,007 9/1958 Lingley 128/2 B 2,880,724 4/1959 Velarde 128/215 3.048175 8/1962 Uddenberg 128/245 3,281,023 10/1966 Bruck et a1. 128/218 C X 3,356,089 12/1967 Francis 128/221 3,380,448 4/1968 Sadove et a1. 128/215 3,404,687 lO/1968 Moyer 128/221 3,630,192 12/1971 Jamshidi 128/2 B Primary E.raminer1(yle L. Howell Attorney, Agent, or Firm.1ohn D. Pope, 111

[57] ABSTRACT A method for injecting x-ray contrast media into the wall of the uterus a predetermined depth to make a record of the venous plexus system of the uterus. A straight rod probing member having a probing surface for probing against the uterine wall is inserted into the uterus and a piercing member arranged to be combined with a syringe is slidably disposed in the probing member and extended a predetermined amount from the probing surface when the probing surface contacts the uterine wall. X-ray opaque material is then injected into the spongy layer of the uterus and an X-ray record made of the passage of said opaque material through the venous plexus system.

6 Claims, 6 Drawing Figures METHOD FOR INJECTING X-RAY CONTRAST MEDIA FOR VENOGRAPHY OF THE FEMALE PELVIS This is a continuation of application Ser. No. 269,038, filed July 5, 1972, now abandoned.

This invention is directed to new and useful method for supplying x-ray contrast media to blood vessels in the uterus.

In making an x-ray examination of the uterus and the venous vascular system therein it is known to make an incision in the abdomen and to pass a needle containing the contrast medium, such as Vascoray or Conray 30 manufactured by Mallinckrodt Chemical Works, through the incision directly into the uterine wall. Such a procedure involves the risk that the x-ray contrast media will not be entirely localized in the uterus since the needle that injects the contrast media can have insufficient or excess penetration. There is also a danger that the needle will accidentally penetrate and injure the intestine or other vital organ of the body surrounding the uterine wall.

Among the several objects of the present invention may be noted the provision of a novel method of probing and penetrating method for supplying x-ray contrast media tothe uterine wall; a novel method for supplying x-ray contrast media to the uterus by direct insertion of a device through the vaginal opening; a novel probing and penetrating method for supplying fluid to a body surface within a body cavity at a predetermined depth from the body surface, a novel probing and penetrating method for supplying x-ray contrast media to the uterus at a predetermined location therein; and a novel probing and penetrating method for locating a wall portion of an internal body cavity and penetrating the located wall portion a predetermined depth. Other objects and features will be in part apparent and in part pointed out hereinafter.

The present invention relates to a novel intrauterine method for probing the uterus to locate a desired portion of the uterine wall and for injecting a supply of x-ray contrast media a predetermined depth in the uterine wall.

In one embodiment the intrauterine device used in the method comprises an elongated probe member having a probing surface at one end thereof and a piercing member extensible a predetermined amount from the probing surface. The piercing member penetrates the uterine wall to a predetermined depth measured by the extension of the piercing member from the probing surface. The piercing member is combined with a syringe to inject the x-ray contrast media into the uterine wall. In another embodiment the length of the piercing member can be varied.

The invention accordingly comprises the method hereinafter described, the scope of the invention being indicated in the following claims.

In the accompanying drawings, in which several of various possible embodiments of apparatus for carrying out the method of the invention are illustrated,

FIG. 1 is a perspective view of the unassembled members of an intrauterine device incorporating one embodiment of my invention;

FIG. 2 is an enlarged fragmentary plan view showing the members of the intrauterine device in an assembled condition;

FIG. 3 is a sectional view taken along the line 33 of FIG. 2;

FIG. 4 is a sectional view taken along the line 4-4 of FIG. 2;

FIG. 5 is a sectional view taken along the line 5-5 of FIG. 2 and further illustrates a fragmentary section of a uterine wall;

FIG. 6 is a modification of the intrauterine device of FIGS. 1-5.

Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.

Referring now to the drawings for a detailed description of the apparatus for carrying out the present invention, and intrauterine device incorporating one embodiment thereof is generally indicated at 10. Intrauterine device 10 comprises a probing member 12, a piercing member 14 insertable in probing member 12, and a stylet member 16 insertable in piercing member 14.

Probing member 12 is formed of any suitable inert material such as monel metal or plastic and comprises an elongated holiow rod 18 having a bulb shaped end portion 20. Bulb end portion 20 includes a hollow threaded bushing 21 arranged to bear against an O-ring 23 made of any suitable material. Bushing 21 conforms to the contour of bulb end portion 20, and includes spaced holes 25 formed therein. A pair of oppositely disposed handle rings 22, 22 are a fixed to rod 18 near an end portion 24 thereof. Probing member 12 is also provided with a longitudinal bore 26 extending through rod 18 from end portion 20 to end portion 24. End portion 24 of rod 18 includes a cup-shaped counter bore 28 communicating with longitudinal bore 26. Probing member 12 can be entirely molded in one piece or the component parts thereof such as rod 18, rings 22, 22 and bulb end portion 20 can be separately manufactured and assembled in any suitable known manner.

Piercing member 14 is formed of any suitable material such as stainless steel and comprises an elongated tube 30 having one end 32 secured to a first support member 34 and an opposite end 36 tapered to a point. The hollow portion of tube 30 is designated 38. First support member 34 has a hollow portion 40 communicating with hollow portion 38 of tube 30 and also includes an engaging portion 42 complementary in shape to cup-shaped counter bore 28 of rod 18. First support member 34 further includes an adapter portion 44 engageable with any suitable known syringe (not shown). Adapter portion 44 includes a flange 46 having a key slot 48 provided therein. A cup-shaped counter bore 49 at flange 46 communicates with hollow portion 40 of first support member 34.

Stylet member 16 is formed of any suitable material I such as stainless steel and comprises an elongated wire 50 having one end 52 secured to a second support member 54. An opposite end 56 of second support member 54 is tapered to a point, the taper angle of end 56 corresponding to the taper angle of end 36 of tube 30. Second support member 54 also includes an engaging portion 58 complementary in shape to cup-shaped counter bore 49 of first support member 34. A flange 60 formed around the periphery of engaging portion 58 is provided with a depending key projection 62.

In using intrauterine device 10 bulb end portion 20 of probing member 12 is inserted through the vaginal opening into the uterus. Probing member 12 is manipulated at handle rings 22, 22 such that bulb end portion probes against a portion of the uterine wall such as a fundus 64, which fundus is shown in fragmentary section in FIG. 5.

It is desirable to control the depth of penetration of tube into fundus 64 to ensure that tube 30 does not pass entirely through fundus 64 and out of the uterus. It is also desirable to obtain sufficient penetration of tube 30 into fundus 64 to ensure that the injected x-ray contrast media will be forced into the uterine circulatory system.

I have found that the uterine wall is generally 2-3 centimeters thick and comprises spaced outer layers of muscular tissue sandwiching an inner layer of spongy tissue. The spongy inner layer contains blood vessels or venous plexus and lies at least A centimeter beneath the endometrium. The uterine muscular tissue strongly resists injection of any liquid therein whereas the spongy layer containing the plexus provides minimal resistance to injection of liquid therein. X-ray contrast media injected into the plexus tends to follow the drainage current of the venous system or blood circulation network mixing with the blood such that the venous vascular system shows up on the x-ray film. It is thus advantageous to inject the x-ray contrast media to a depth below the endometrium, that is within the spongy layer of tissue.

Stylet end 56 is placed in counter bore 49 of first support member 34 and wire 50 is inserted into hollow portion 38 of piercing tube 30 until engaging portion 58 engages counter bore 49. The diameter of wire 50 is sized to form a slip fit into hollow portions 38 and 40 of tube 30 and first support member 34, respectively. When engaging portion 58 is nested in counter bore 49, second support member 54 is rotated to a position wherein key projection 62 engages key slot 48. thereby aligning tapered ends 36 and 56 of tube 30 and wire as shown in FIG. 5. Tapered end 56 of wire 50 thus plugs hollow portion 38 of tube end 36. The length of wire 50 necessary to plug tube end 36 can be determined by measuring the distance from counter bore 49 to tube end 36 when stylet member 16 is inserted in piercing member 14 such that engaging portion 42 nests in counter bore 49 and key projection 62 is aligned in key slot 48. This measurement would also include allowance for attachment of wire 50 to second support member 54.

The sub-assembly of stylet member 16 and piercing member 14 is next assembled to the vaginally disposed probing member 12 by inserting tapered ends 36 and 56 of tube 30 and wire 50 into bore 26 at end 24 of rod 18. The diameter of bore 26 is sized to permit slidable insertion of tube 30 therein.

Insertion of piercing member 14 and stylet member 16 in probing member 12 is limited by the engagement of engaging portion 42 with counter bore 28. This engagement defines an insertion limit position of tube 30 in probing member 12.

To control the depth of penetration of piercing tube 30 into fundus 64 piercing tube 30 is fashioned to a predetermined length such that when piercing tube 30 is in its insertion limit position tapered end 36 will project approximately /3 centimeter beyond bulb end portion 20. The length of tube 30 necessary to enable tube end 36 to project A; centimeter beyond bulb end portion 20 when piercing member 14 is in its insertion limit position can be determined by measuring the distance from counter bore 28 to bulb end portion 20 and making allowance for the /a centimeter penetration depth plus the amount of tube length needed to affix tube 30 to first support member 34. In this manner the depth of penetration of tube 30 in fundus 64 is predetermined and thereby controlled.

With piercing member 14 disposed in probing member 12 at the insertion limit position, tapered end 36 of tube 30 extends beyond bulb end portion 20 the desired predetermined amount. Tapered end 56 of wire 50 prevents any body material from entering tube end 36. Since bulb end portion 20 of probing member 12 has been positioned against fundus 64 tapered end 36 of probing member 12 penetrates fundus 64 to the desired predetermined depth. Stylet 16 is then withdrawn from piercing member 14 and any suitable known syringe (not shown) containing x-ray contrast media is connected to first support member 34 at adapter portion 44. X-ray contrast medial supplied by the syringe is thus injected into fundus 64 a predetermined depth. I have found that when tapered end 36 faces the left as shown in FIG. 5 the direction of flow of x-ray contrast media within fundus 64 is to the left. The reverse would be true when tapered end 36 faces the right. Thus by providing a guidemark 35 on first support member 34 as shown in FIG. 2 to indicate the direction that tapered end 36 in facing, one can control the direction of flow of x-ray contrast media in the blood stream of the venous plexus.

Bulb end portion 20 in addition to serving as a probing surface to locate fundus 64 or other portions of the uterine wall also functions as a tampon during injection of x-ray contrast media into the venus plexus. Bulb end portion 20 thus helps keep the x-ray contrast media from leaking out of the penetrated uterine wall area whereas the blood circulation system in the fundus receives the injected x-ray contrast media which is forced into the penetrated area of the vascular plexus mixing with the blood within the vessels and being carried along allowing the outline of this stream to be visualized by x-ray thus demonstrating the vascular system within the uterus and its adnaxal apendeges as well. Bushing 21 and O-ring 23 cooperate to form a seal against tube 30 thereby preventing any body fluid or x-ray contrast media from flowing into rod 18. Any suitable wrench (not shown) having pins engageable with holes 25 can be used to adjust or remove bushing 21 from bulb end portion 20.

Probing member 12 can be tilted or otherwise manipulated in the uterus to cause bulb end portion 20 to probe against varying locations on the uterine wall for injection of x-ray contrast media. An x-ray picture can be taken during injection of the contrast media and such picture will provide definitive constrasts representing the venous vascular system. Another x-ray picture can be taken within 10 to 15 seconds after injection of the x-ray contrast media is completed.

Although the depth of penetration of piercing tube 30 is fixed for a particular combination of piercing member 14 and probing member 12 different predetermined depths of penetration can be achieved by combining other probing members similar to probing member 12 but of varying lengths, with a fixed length piercing tube 30 or vice versa.

A modification of device 10 as shown in FIG. 6 and generally designated permits adjustable variation of the depth of penetration of tapered end 36 in a uterine wall. Device 130 comprises a piercing member 132 having a first support member 134 that includes an adapter portion 136, a flange 138, and a cup-shaped counter bore 140, respectively identical to adapter portion 44, flange 46 and bore 49 of device 10. First support member 134 further includes a reduced neck portion 142 having graduations 144 inscribed thereon and a hollow portion 150 extending through neck 142 to bore 140. A tube 152 is affixed to neck 142 at a tube end portion 154. Tube 152 is partially threaded at 156, the remaining portion of tube 152 being unthreaded and identical in structure to tube 30 of device 10.

Device 130 further comprises a probing member 158 comprising a rod 160 having a free end portion 162. Free end portion 162 includes a bore 164 and an internally threaded bushing 166 pressed into bore 164. Rod 160 includes a knurled lock screw 168, threaded therein below bushing 166. The remaining portion of probing member 158 is identical to probing member 12. Stylet member 16 although not shown is incorporated into device 130.

Device 130 is used in the same general manner as device 10. The depth of penetration of tapered end portion 36 of tube 152 can be varied a predetermined amount by rotating first support member 134 in probing member 158 such that threads 156 of tube 152 engage threaded bushing 166. The projection of tapered end portion 36 from bulb end portion is measured by reading the position of free end 162 with respect to graduations 144 on neck 142 of first support member 134. Since the muscular layer of the uterus is substantially more resistant to injection of liquid than the spongy layer, the spongy layer can be located by varying the projection of tapered end 36 from bulb end portion 20 to extend beyond the muscular layer and then into the spongy vascular layer. When tapered end 56 is projected an amount that permits injection of liquid into the uterine wall with minimal resistance the spongy layer has been located. Knurled screw 168 is then tightened to lock piercing tube 152 into its desired position during full injection of x-ray contrast media into the vascular system of the uterus.

As will be apparent to those skilled in the art the intrauterine device can be adapted for use in probing other internal bodily cavities besides the uterus and penetrating the wall structure of these cavities to a predetermined depth. Although the uterus forms an angle of approximately 100 to 110 degrees with the vagina, it is normally quite movable and will easily accomodate devices 10, and 130. Devices 10. and 130 can be manufactured as an entirely reusable or disposable item or, if desired, some of the component parts thereof such as piercing members 14, 132 and stylets 16, 76, can be made in reusable form with probing members 12, 158 fashioned as a disposable item.

Some advantages of the novel intrauterine device evident from the foregoing description include a device that can probe a uterine wall to locate a desired portion thereof, and a device that can inject fluid into a uterine wall to a predetermined depth. Other advantages include a vaginally insertable device for injecting x-ray contrast media into the uterus thereby obviating the procedure of making abdominal incisions. Further advantages include a device that is relatively simple and safe to use regardless of the health of bodily structure adjacent the uterus. Safety arises from the fact that the depth of penetration of piercing tubes 30, and 152 is controlled to substantially eliminate any risk of penetrating bodily structures outside the uterine wall. Still another advantage is a device that can inject x-ray contrast media directly into the uterus to provide x-ray visualization of the venous vascular system with success that approaches a certainty.

In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained.

As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

What is claimed is:

1. The method of making a record of the venous plexus system of a uterus which comprises inserting into the uterus a tubular shaped instrument having a hollow core and a rounded probing end, probing with the instrument to locate the fundus with the rounded end, inserting a hollow needle having a piercing point and an opening through the center of said needle into the hollow core of the tubular instrument to penetrate the surface of the fundus, restraining the needle so that said penetration occurs only to a predetermined depth into but not through the wall of the uterus, injecting x-ray opaque material into the opening in the needle so that it passes through the needle into the spongy layer of said uterus and then exposing an x-ray film to record the passage of said x-ray opaque material through the venous plexus system of the uterus on the x-ray film.

2. The method according to claim 1 in which a plurality of x-ray film pictures are taken at different times subsequent to the injection of the x-ray opaque material.

3. The method of claim 1 in which restraint of the needle is accomplished by limiting the extent to which the needle can project from the end of the tubular instrument.

4. The method of claim 3 in which the passage through the tubular instrument is plugged while penetrating the fundus but the plug is thereafter removed and x-ray opaque material injected through the passage.

5. The method of claim 4 in which the needle is locked in position when it reaches its predetermined projecting position.

6. The method of claim 2 in which the time interval between the first and second picture is approximately 10l5 seconds. 

1. The method of making a record of the venous plexus system of a uterus which comprises inserting into the uterus a tubular shaped instrument having a hollow core and a rounded probing end, probing with the instrument to locate the fundus with the rounded end, inserting a hollow needle having a piercing point and an opening through the center of said needle into the hollow core of the tubular instrument to penetrate the surface of the fundus, restraining the needle so that said penetration occurs only to a predetermined depth into but not through the wall of the uterus, injecting x-ray opaque material into the opening in the needle so that it passes through the needle into the spongy layer of said uterus and then exposing an x-ray film to record the passage of said x-ray opaque material through the venous plexus system of the uterus on the x-ray film.
 2. The method according to claim 1 in which a plurality of x-ray film pictures are taken at different times subsequent to the injection of the x-ray opaque material.
 3. The method of claim 1 in which restraint of the needle is accomplished by limiting the extent to which the needle can project from the end of the tubular instrument.
 4. The method of claim 3 in which the passage through the tubular instrument is plugged while penetrating the fundus but the plug is thereafter removed and x-ray opaque material injected through the passage.
 5. The method of claim 4 in which the needle is locked in position when it reaches its predetermined projecting position.
 6. The method of claim 2 in which the time interval between the first and second picture is approximately 10-15 seconds. 